About This Opportunity

Our client is seeking an exceptional Vice President of Operations to lead our manufacturing operations, supply chain, and distribution network as we scale our innovative medical device solutions. This is a pivotal leadership role for a proven operations executive who thrives in high-growth environments and has deep expertise in medical device manufacturing.

You'll have the opportunity to build and scale operations from the ground up, establish manufacturing partnerships, implement robust MRP systems, and create distribution networks that will support our company's ambitious growth trajectory.

What You'll Do

Manufacturing & Production Leadership

• Develop and implement scalable manufacturing strategies for multiple Class II disposable sterile medical devices
• Establish strategic manufacturing partnerships or build internal production capabilities
• Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance
• Oversee sterile packaging and device sterilization processes
• Implement lean manufacturing principles and drive continuous improvement initiatives

Supply Chain & Systems Development

• Build comprehensive Material Requirements Planning (MRP) systems from inception using NetSuite
• Establish and manage supplier relationships and vendor qualification processes
• Develop sophisticated inventory management strategies for raw materials, components, and finished goods
• Create demand forecasting models and production planning processes
• Implement supply chain risk management and business continuity plans

Quality & Regulatory Excellence

• Ensure all manufacturing processes comply with FDA regulations for Class II medical devices
• Maintain ISO 13485 quality management system standards
• Oversee comprehensive quality control and quality assurance programs
• Support regulatory submissions and FDA interactions

Distribution & Logistics

• Design and build product distribution network and fulfillment capabilities
• Develop warehousing and logistics strategies including facility planning
• Implement traceability systems for lot tracking and recall procedures
• Create customer service and technical support frameworks

Team Leadership & Organizational Development

• Build and lead cross-functional operations teams including manufacturing, facilities, supply chain, and logistics
• Establish organizational structure and operational processes
• Develop talent acquisition strategies for critical operational roles
• Foster a culture of operational excellence and continuous improvement

Financial Management & Strategy

• Develop operational budgets and cost models
• Implement cost reduction initiatives while maintaining quality standards
• Establish key performance indicators (KPIs) and operational metrics
• Support financial planning and investor reporting requirements

What You Bring

Education & Certifications

• Bachelor's degree in Engineering, Operations Management, or related field (required)
• MBA or advanced degree (preferred)
• Professional certifications such as ASQ, APICS, or PMP (plus)

Experience Requirements

• 10+ years of operations leadership experience in the medical device industry
• Previous VP of Operations role in a medical device startup (strongly preferred)
• Proven track record scaling manufacturing operations for Class II medical devices
• Experience with single-use disposable sterile medical device production
• Experience in startup or high-growth environments
• Experience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systems
• Demonstrated success building MRP systems and supply chain operations from early stage
• Experience with direct-to-hospital sales and distribution models

Required Skills & Abilities

• Deep knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
• Proven ability to build and scale operations teams
• Thorough knowledge of materials and production scheduling systems, MRP, and cycle counting
• Experience working within FDA/ISO regulated environments
• Experience managing departmental budgets and P&L responsibility
• Experience complying with environmental health and safety regulations
• Demonstrated proficiency with problem-solving tools (FMEA, DOE, SPC, etc.) and statistical techniques
• Expertise interfacing with R&D and manufacturing groups to optimize device design and processes
• Strong project management and cross-functional collaboration skills
• Experience working with contract manufacturers and supply chain partners
• Financial acumen with P&L responsibility experience
• Excellent communication skills with ability to present to board and investors
• Strong negotiation skills with internal and external stakeholders